NCT06364046尚未招募不适用
Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC:A Prospective, Single-center, Randomized, Open, Double-arm Clinical Trial
The Central Hospital of Lishui City1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years old, regardless of gender;
- •SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
- •TNM stage II-IV;
- •ECOG PS score ≤2;
- •Predicted survival time more than 3 months;
- •Provision of signed informed consent.
排除标准
- •Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
- •Concurrent presence of other incurable malignant tumors;
- •White blood cell count less than 3×10^9/L, neutrophil absolute count less than 1.5×10^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10^9/L, hemoglobin concentration less than 90 g/L;
- •Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
- •Uncorrectable coagulopathy or concurrent active hemoptysis;
- •Complicated with active infection requiring antibiotic treatment;
- •Uncontrolled hypertension, diabetes, or cardiovascular disease;
- •Allergy to contrast agents;
- •Women who are pregnant or lactating.
研究组 & 干预措施
Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab
Experimental
干预措施: Drug-eluting beads bronchial arterial chemoembolization (Procedure)
Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab
Experimental
干预措施: Serplulimab (Drug)
Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab
Active Comparator
干预措施: Serplulimab (Drug)
Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab
Active Comparator
干预措施: Intravenous chemotherapy (Procedure)
结局指标
主要结局
Objective response rate
时间窗: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria at 1 month, 3 months, and 6 months , assessed up to 12 months
Evaluation index of clinical efficacy of anticancer drugs.
次要结局
- Progression Free Survival(The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years)
- The incidence of adverse events and serious adverse events(Time Frame: From date of randomization to every follow-up time, assessed up to 2 years.)
- Time to tumor untreatable progression(The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.)
- Eastern Cooperative Oncology Group Score(The patient's performance status score is divided into 6 grades. The lowest grade is 0, and the highest grade is 5. The patient's physical state deteriorates as the grade rises,assessed up to 2 years..)
- Recurrence rate of hemoptysis(From date of randomization to every follow-up time, assessed up to 2 years.)
- Pain assessment(From date of randomization to every follow-up time, assessed up to 2 years.)
- Overall Survival(Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.)
- Tumor biomarkers(From pre-procedure to every follow-up time, assessed up to 2 years.)
- Disease Control Rate(Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.)
- Duration of Overall Response(The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months)
- Quality of life Questionare-Core score(From date of randomization to every follow-up time, assessed up to 2 years.)
研究者
研究点 (1)
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